ZipRecruiter
Group Medical Director, Patient Safety
ZipRecruiter, Irvine, California, United States, 92713
Overview
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on peoples lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and TikTok.
Purpose Group Medical Director manages other Associate Medical Directors, Medical Directors, and Senior Medical Directors. Leads Product Safety Teams (PST) and PST leads (and could support one large product as the PST Lead) and ensures safety of late stage and post marketing hematology-oncology portfolio (e.g., surveillance, signal detection, validation and assessment). Interpreting regulations related to pharmacovigilance supporting all patient safety activities. Experts on hematology-oncology late stage group of assets with similar mechanism of action (overarching across assets).
Responsibilities
Connectors within R&D particularly with key functions (Reg, ASL, Risk Mgt, etc)
Asset strategy lead safety representatives for larger programs (late stage)
Understand MOA in close collaboration with preclinical, clinical pharmacy, clinical development, and discovery
Work closely with Executive Medical Director to establish safety strategy for each indication and across assets with similar MOA
Lead and guide the safety physicians on data review (clinical and beyond) and interpretations across assets with similar MOA
Proactively seek to understand “WHY” a safety concern or risk emerges and “How” to mitigate it
Understand and apply pharmacology and chemistry to effectively conduct safety surveillance
Responsible for safety surveillance for pharmaceutical / biological / drug – device combined products
Lead and set the strategy for key pharmacovigilance documents, including medical safety assessments, regulatory responses, and risk management plans
Apply current regulatory guidance as appropriate for safety surveillance and authorship of PV documents
Analyze and interpret aggregate safety data and communicate these analyses to cross-functional teams
Effectively write, review and provide input on technical documents independently
Oversight and responsibility for leading the strategy for periodic reports (PSURs, PADERs, etc.)
Oversight of safety surveillance and pharmacovigilance activities for products in clinical trials and post marketing
Responsible for implementing risk management strategies for assigned products
Proactively engaging, inspiring, coaching and mentoring team and colleagues
Manages other Associate Medical Directors, Medical Directors, Senior Medical Directors: performance and talent management, coaching and development
Assumes responsibility for coordinating and overseeing safety related activities at a product level across multiple indications or multiple related products for the same indication
Qualifications
MD / DO with 2+ years of patient management experience
Master of Public Health or PhD is in addition to MD / DO, not required
8 - 10 years of Pharmacovigilance / Clinical Development experience in the pharmaceutical industry
Ability to analyze and guide analysis of clinical data and epidemiological information
Ability to present recommendations / opinions in group settings both internally and externally
Write, review and provide input on technical documents
Work collaboratively and lead cross-functional teams
Ability to lead cross-functional teams in a collaborative environment
Fluency, both written and oral, in English
Evaluate and make independent decisions; ability to work effectively amid uncertainty and complexity, and to multitask
Experiences / Leadership traits
Ability to work collaboratively with colleagues with different areas of expertise (e.g., epidemiology, statistics)
Ability to make independent decisions
Ability to influence cross-functional stakeholders internal and across industry and regulatory authorities
Clear understanding of PV and clinical development and monitoring clinical trial and post-marketing safety
Respect for other opinions and inclusivity of different points of view
Additional Information
Compensation is described as the range of possible base pay for this role at posting based on job grade; individual compensation depends on factors including location and may vary from the posted range. The range may be modified in the future.
We offer a comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) for eligible employees.
This job is eligible to participate in short-term and long-term incentive programs.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, visit https://www.abbvie.com/join-us/reasonable-accommodations.html
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Purpose Group Medical Director manages other Associate Medical Directors, Medical Directors, and Senior Medical Directors. Leads Product Safety Teams (PST) and PST leads (and could support one large product as the PST Lead) and ensures safety of late stage and post marketing hematology-oncology portfolio (e.g., surveillance, signal detection, validation and assessment). Interpreting regulations related to pharmacovigilance supporting all patient safety activities. Experts on hematology-oncology late stage group of assets with similar mechanism of action (overarching across assets).
Responsibilities
Connectors within R&D particularly with key functions (Reg, ASL, Risk Mgt, etc)
Asset strategy lead safety representatives for larger programs (late stage)
Understand MOA in close collaboration with preclinical, clinical pharmacy, clinical development, and discovery
Work closely with Executive Medical Director to establish safety strategy for each indication and across assets with similar MOA
Lead and guide the safety physicians on data review (clinical and beyond) and interpretations across assets with similar MOA
Proactively seek to understand “WHY” a safety concern or risk emerges and “How” to mitigate it
Understand and apply pharmacology and chemistry to effectively conduct safety surveillance
Responsible for safety surveillance for pharmaceutical / biological / drug – device combined products
Lead and set the strategy for key pharmacovigilance documents, including medical safety assessments, regulatory responses, and risk management plans
Apply current regulatory guidance as appropriate for safety surveillance and authorship of PV documents
Analyze and interpret aggregate safety data and communicate these analyses to cross-functional teams
Effectively write, review and provide input on technical documents independently
Oversight and responsibility for leading the strategy for periodic reports (PSURs, PADERs, etc.)
Oversight of safety surveillance and pharmacovigilance activities for products in clinical trials and post marketing
Responsible for implementing risk management strategies for assigned products
Proactively engaging, inspiring, coaching and mentoring team and colleagues
Manages other Associate Medical Directors, Medical Directors, Senior Medical Directors: performance and talent management, coaching and development
Assumes responsibility for coordinating and overseeing safety related activities at a product level across multiple indications or multiple related products for the same indication
Qualifications
MD / DO with 2+ years of patient management experience
Master of Public Health or PhD is in addition to MD / DO, not required
8 - 10 years of Pharmacovigilance / Clinical Development experience in the pharmaceutical industry
Ability to analyze and guide analysis of clinical data and epidemiological information
Ability to present recommendations / opinions in group settings both internally and externally
Write, review and provide input on technical documents
Work collaboratively and lead cross-functional teams
Ability to lead cross-functional teams in a collaborative environment
Fluency, both written and oral, in English
Evaluate and make independent decisions; ability to work effectively amid uncertainty and complexity, and to multitask
Experiences / Leadership traits
Ability to work collaboratively with colleagues with different areas of expertise (e.g., epidemiology, statistics)
Ability to make independent decisions
Ability to influence cross-functional stakeholders internal and across industry and regulatory authorities
Clear understanding of PV and clinical development and monitoring clinical trial and post-marketing safety
Respect for other opinions and inclusivity of different points of view
Additional Information
Compensation is described as the range of possible base pay for this role at posting based on job grade; individual compensation depends on factors including location and may vary from the posted range. The range may be modified in the future.
We offer a comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) for eligible employees.
This job is eligible to participate in short-term and long-term incentive programs.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, visit https://www.abbvie.com/join-us/reasonable-accommodations.html
#J-18808-Ljbffr